Europe – Data generated from ‘Off-Label’ Use of a device under the EU Medical Device Regulation 2017/745

‘Off label use’ is mentioned within the Medical Device Regulation (MDR) in Annex XIV Part B, in the context that manufacturers should proactively identify misuse or off-label use of their device through PMCF activities, however ‘off label use’ or ‘misuse’ is not defined within the MDR.

Searching the term ‘off-label use definition’ will provide many definitions in relation to
pharmaceuticals but yield limited results for a definition associated specifically with medical devices.

However the interpretation of off label can be considered generally the same.
Table 1 provides some common interpretations from various regulators and medical device
organizations of the term ‘off-label’ in the context of medical devices…